Comparison of the effect of remifentanil and nitroglycerin on intraoperative blood pressure and complications during and after rhinoplasty in the surgical center under the supervision of Shahrekord University of Medical Sciences
Design
This study is a double-blind clinical trial that was conducted in 1398 after the approval of the proposal and obtaining permission . First, 50 patients who volunteered for rhinoplasty surgery referred to Dr. Afzali Shahrekord clinic and had inclusion criteria and no exclusion criteria, were selected and randomly divided into two groups of 25 based on a random number table.
Settings and conduct
First, 50 volunteer patients for rhinoplasty surgery referred to Dr. Afzali Shahrekord clinic and having inclusion criteria and no exclusion criteria were selected and randomly divided into two groups of 25 based on a table of random numbers. Location of surgery: Surgery centers under supervision Shahrekord Medical University
Participants/Inclusion and exclusion criteria
Age between 18 and 45 years
Classification of the American Anesthesia Association in Physical Classes 1 and 2
Satisfaction of the company in the project
No history of bleeding disorders in the patient
No history of hypertension in the patient
Do not take drugs that alter coagulation profiles such as aspirin
Platelet counts
Intervention groups
Patients referred for rhinoplasty with concomitant anesthesia to control blood pressure in the first group of remifentanil (0.1-0.3 μg / kg / min) and in the second group of nitroglycerin (0.5-1 μg / min) Kg / min) and their blood pressure is monitored before, during and after surgery and the effect of these two drugs is compared.
Main outcome variables
blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210508051228N1
Registration date:2021-06-19, 1400/03/29
Registration timing:retrospective
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Ali Hasanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0064
Email address
a.dehkordi1398@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-09-21, 1399/06/31
Trial completion date
2020-12-20, 1399/09/30
Scientific title
Comparison of the Effect of Remifentanil and Nitroglycerin on Intraoperative Blood Pressure and Complications During and After Rhinoplasty
Public title
Comparison of the Effect of Remifentanil and Nitroglycerin on Intraoperative Blood Pressure and Complications During and After Rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-Age between 18 and 45 years 2- Classification of the American Anesthesia Association in Physical Classes 1 and 2 3- Satisfaction of the company in the project 4-No history of bleeding disorders in the patient 5-No history of hypertension in the patient 6-Do not take drugs that alter coagulation profiles such as aspirin 7-Platelet counts and normal coagulation tests
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple-individual randomization - 50 patients who volunteered for rhinoplasty surgery referred to Dr. Afzali Clinic in Shahrekord and with inclusion criteria and no exclusion criteria were selected and randomly divided into two groups of 25 based on a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial that was conducted in 1398 after the approval of the proposal and obtaining permission . First, 50 patients who volunteered for rhinoplasty surgery referred to Dr. Afzali Shahrekord clinic and had inclusion criteria and no exclusion criteria, were selected and randomly divided into two groups of 25 based on a random number table.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SKUMS.REC.1398.076
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Y81
ICD-10 code description
General- and plastic-surgery devices associated with adverse incidents
Primary outcomes
1
Description
blood pressure
Timepoint
Before, during and after rhinoplasty
Method of measurement
The vital signs monitoring device of Mizan Teb Company
Secondary outcomes
1
Description
The surgeon's satisfaction with the surgical site
Timepoint
Before, during and after rhinoplasty
Method of measurement
Vital Signs Monitoring Company of Mizan Teb Company
Intervention groups
1
Description
Intervention group 1: People receiving remifentanil 0.1-0.3 μg / kg / min at the same time as anesthesia before and during rhinoplasty Intervention
Category
Treatment - Surgery
2
Description
"Intervention group 2:" Receiving nitroglycerin (0.5 -1.0 mg / kg / min) at the same time as anesthesia before and during rhinoplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Marzieh Naderi
Street address
Ordibehesht Building
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
Dr.afzali.sl@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Moezzi
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
mmoezzi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Lotfollah Afzali
Position
Research Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Cosmetic Surgeon
Street address
Kashani.st
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
Dr.afzali.sl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Ali Hassanpourdehkordi
Position
Research Consultant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
alihassanpourdehkordi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Lotfollah Afzali
Position
Master Guid
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Cosmetic Surgery
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
Dr.afzali.sl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
In the full text of the thesis
When the data will become available and for how long
After the explanation of the thesis
To whom data/document is available
Researchers and students of the centers
Under which criteria data/document could be used
Referral of research work references
From where data/document is obtainable
University Library
What processes are involved for a request to access data/document